The trial is a randomized phase I/II open label trial, with a six-patient safety lead-in cohort, of ONCOS-102 and pemetrexed/cisplatin, the current standard of care chemotherapy, in 1st and 2nd line patients with unresectable malignant pleural mesothelioma. The trial aims to assess safety, tumor targeted immune activation and clinical benefit of the combination of ONCOS-102 and chemotherapy compared to chemotherapy alone.

The independent Data and Safety Monitoring Board (DSMB) have now reviewed all six patients in the safety lead-in cohort of the trial. No concerns were raised, and the DSMB have recommended that the randomized part of the trial can be initiated, with recruitment of another 24 patients.

In addition, early immune activation has been assessed for a subset of the patients. Systemic release of several pro-inflammatory cytokines was observed (3/3 patients analyzed), demonstrating that the treatment triggers an innate immune response. Also, there was an increase in the relative level of tumor infiltrating cytotoxic CD8+ T-cells (2/2 patients with pre- and post-treatment biopsies analyzed), indicating an activation of the adaptive immune system in the lesions. These data are important, as they show that the treatment of ONCOS-102 in combination with chemotherapy induces both innate and adaptive immune activation in patients, as well as triggering changes in the tumor microenvironment, which indicate that the tumors may become susceptible to an attack by the immune system.

Magnus Jäderberg, CMO of Targovax, said: “We are very pleased that the safety lead-in cohort was completed without any concerns, and that we now can move into the randomized part of the trial. The systemic and lesional immune activation are in line with what we saw in the mesothelioma patients from our phase I trial, in which there was an associated clinical response. It will therefore be interesting to follow what clinical benefits may be seen in the subsequent randomized part of the ongoing trial.”

Targovax (OSE:TRVX) is a clinical stage company focused on developing and commercializing novel immuno-oncology therapies to target, primarily, treatment-resistant solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.

The Company’s development pipeline is based on two novel proprietary platforms:

The first platform, ONCOS, uses oncolytic viruses as potential multi-target, neo-antigen therapeutic cancer vaccines. ONCOS uses an adenovirus that has been engineered to be an immune activator that selectively targets cancer cells. In phase I trials it has demonstrated immune activation at lesional level which was associated with clinical benefit. In an ongoing phase I trial in advanced melanoma we expect important proof of concept data for checkpoint inhibitor refractory patients.

The second platform, TG, are neo-antigen cancer vaccines designed to specifically treat tumors that express mutated forms of RAS. Mutations to the RAS protein are common in many cancers and are known to drive aggressive disease progression and treatment resistance. There is a high unmet medical need for therapies that are effective against tumors that express these mutations. The TG platform’s therapeutic potential stems from its ability to enable the patient’s immune system to identify and destroy tumors bearing any RAS mutations. In early 2017, key proof of concept data for the TG platform from a clinical trial of TG01 in resected pancreatic cancer patients showed encouraging overall survival and will give guidance for the future clinical development of this platform.

Targovax’s development pipeline has three novel therapeutic candidates in clinical development covering six indications.

Both platforms are protected by an extensive portfolio of IP and know-how and have the potential to yield multiple product candidates in a cost-effective manner. Additionally, Targovax has other products in early stages of development.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.